Kornimate/medical-research-clean huggingface dataset:
psychological predictors in colorectal ibd surgery recovery

Conditions: Inflammatory Bowel Diseases

Summary: this is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal surgery for inflammatory bowel diseases (ibd), including crohn's disease and ulcerative colitis.

the chronic nature of inflammatory bowel disease (ibd) leads to a significant impact on patients' lives, beyond intestinal symptoms alone. the sequelae of this can be seen in the increased rates of depression and reduced quality of life (qol). surgery may provide a way to effectively induce long-term symptoms remission, although there is a short postoperative transitory period whereas quality of life might decrease. over the last years, increasing interest has been gained by perioperative recovery protocols, aiming to accelerate functional recovery and to reduce complications. some of these protocols include an in-depth discussion with both dedicated nurses and/or surgeons to decrease surgery-associated stress reaction. nevertheless, no one of the proposed protocols has included a psychological assessment in order to correlate it with functional recovery. we suggest that studying the psychological characteristics of the patients (with a specific focus on mindfulness) could lead to open a new research front to optimize patients' outcomes.

Eligibility criteria:
inclusion criteria: * patients \> 18 years old (both males and females). * patients diagnosed with inflammatory bowel disease (crohn's disease or ulcerative colitis). * patients scheduled for elective open or laparoscopic surgery for curative intent. exclusion criteria: * patients unable to give the written informed consent. * patients \< 18 years old. * patients undergoing surgery in emergency setting. * patients with pre-operative evidence of colorectal cancer or high grade/low grade dysplasia. * pregnant or breastfeeding patients. * any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia)

Keywords: inflammatory bowel diseases mindfulness psychological predictors colorectal surgery
triple negative breast cancer and germline hereditary breast and ovarian cancer mutation carrier registry

Conditions: Breast Cancer; Hereditary Breast and Ovarian Cancer

Summary: progect is a registry for patients with triple negative breast cancer (tnbc) or patients who have an identified germline mutations (such as a mutation on the brca1 or brca2 genes).

this study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. this information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.

Eligibility criteria:
inclusion criteria include: triple negative breast cancer * er/pr \<10% and her negative per current asco/cap guidelines * stages i-iv * any age at diagnosis * patient must be within 5 years of diagnosis * eligible regardless of genetic testing status * genetic testing recommended for patients meeting nccn and medicare guidelines and/or germline mutation carriers * patients with deleterious or uncertain mutations in hboc genes (brca, pten, p53, -palb2 etc) are eligible regardless of type/site of cancer * healthy patients harboring mutations also eligible * there is no time limit from the time of diagnosis of cancer and enrollment. * eligible regardless of personal history of cancer exclusion criteria include: triple negative breast cancer -patient is not within five years of diagnosis germline mutation carriers: -patient only carries a hboc mutation that is classified as "polymorphism" of "favor polymorphism"

Keywords: triple negative breast cancer tnbc hereditary breast and ovarian cancer hboc prospective registry
avastin for pdr (proliferative diabetic retinopathy)

Conditions: Retinal Detachment; Diabetic Retinopathy

Summary: the purpose of this study is to determine the effect of anti-vegf drug (avastin) adminstration in eyes prior to surgical treatment for traction retinal detachment (trd) in patients with proliferative diabetic retinopathy (pdr).

traction retinal detachment (trd) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (ctgf) and vascular endothelial growth factor (vegf) in the eye. small, nonrandomized studies have suggested that pre-operative adjunctive anti-vegf administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.

Eligibility criteria:
inclusion criteria: * active fibrovascular proliferation due to pdr with trd given pre-operative clearance for pars plana vitrectomy (ppv) and trd repair. exclusion criteria: * dense vitreous hemorrhage * inability to follow-up for surgery within 3-7 days after intravitreal injection * history of stroke, thromboembolic event, or heart attack within the last 6 months * less than 18 years of age * pregnancy

Keywords: traction retinal detachment (pdr) proliferative diabetic retinopathy (pdr)
effects of a non-calcium based phosphate binder on fgf23 levels in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: fibroblast growth factor 23 (fgf23) is a molecule that has been implicated in the homeostasis of phosphorus. elevated fgf23 levels are well-documented in patients with chronic kidney disease (ckd) and are inversely correlated with glomerular filtration rate (gfr). fgf23 levels are also predictive of progression of ckd and predict mortality in ckd. although studies in normal individuals suggest that phosphorus intake is related to fgf23 levels, the effect of dietary and pharmacologic phosphate restriction on fgf23 levels in patients with ckd has never been reported. our objectives are to determine if phosphate reduction through the use of non-calcium based phosphate binder will decrease serum fgf23 levels. the investigators will also be investigating associations of elevation in fgf 23 levels with commonly encountered co-morbidities in ckd patients such as coronary artery disease, diabetes mellitus, and hypertension.


Eligibility criteria:
inclusion criteria: * adults between ages 18-80 years old, with a gfr less than or equal to 50 ml/min/1.73 m2 as determined by the modification of diet in renal disease (mdrd) formula will be included. exclusion criteria: * patients will be excluded if they have a history of renal transplant or are pregnant. in addition, patients with dysphagia, swallowing disorders, severe gi motility disorders, severe constipation, history of major gastrointestinal surgery and patients taking levothyroxine for hypothyroidism will be excluded.
prospective evaluation of asians with crt for heart failure

Conditions: Heart Failure; Cardiac Resynchronisation Therapy

Summary: aim:to determine the baseline characteristics of heart failure patients in singapore undergoing cardiac resynchronization therapy (crt); the long term outcome and predictors of response to crt. methodology:among patients undergoing crt for severe heart failure according to indications stipulated in international cardiology guidelines, baseline demographic data is collected. age, gender, nyha functional class, co-morbidities, qrs width on ecg, presence of left bundle branch block pattern on ecg, presence of atrial fibrillation, left ventricular ejection fraction (lvef) on echocardiogram, ventricular dimensions, 6 min walk test distance are collected. in addition, during the crt implant procedure, blood is drawn from the vascular access and analysed for nt-pro bnp levels and other biomarkers of heart failure. the echocardiographic and ecg parameters and blood biomarkers are reanalysed at 6 months and 12 months following crt implant. response to crt is defined as a reduction in the ilvesv (left ventricular end-systolic volume index to body surface area) of \>/= 15% and/or an increase in the lvef of \>/= 10%.

among patients undergoing crt for severe heart failure according to indications stipulated in international cardiology guidelines, baseline demographic data is collected. age, gender, nyha functional class, comorbidities, qrs width on ecg, presence of left bundle branch block pattern on ecg, presence of atrial fibrillation, left ventricular ejection fraction (lvef) on echocardiogram, ventricular dimensions, 6 min walk test distance are collected. in addition, during the crt implant procedure, blood is drawn from the vascular access and analysed for nt-pro bnp levels and other biomarkers of heart failure. the echocardiographic and ecg parameters and blood biomarkers are reanalysed at 6 months and 12 months following crt implant. response to crt is defined as a reduction in the ilvesv (left ventricular end-systolic volume index to body surface area) of \>/= 15% and/or an increase in the lvef of \>/= 10%.

Eligibility criteria:
inclusion criteria: * broad qrs (\>120 ms) * ef \< 40% * symptomatic heart failure * not on optimal medical therapy exclusion criteria: * pregnant * \< 18 years of age * infection * unable to consent
ketotifen in non-alcoholic fatty liver disease patients

Conditions: Hepatic Disease

Summary: the aim of this study is to investigate the safety and efficacy of using ketotifen in patients with nafld patients without cirrhosis

nonalcoholic fatty liver disease (nafld) is characterized by the accumulation and deposition of fats in the hepatocytes which affect the liver structure and function. causes of nafld vary but mainly attributed to dyslipidemia and obesity. prevalence of nafld has been raised over years from 25% in 2005 to over 37% in 2016 and continues to increase to become one of the most common chronic liver disease (li j et al., 2019). the disease progress from steatosis and inflammatory infiltration that is known as nonalcoholic steatohepatitis (nash) to liver fibrosis, cirrhosis, and ultimately hepatocellular carcinoma. despite these serious outcomes, no definitive known approved medication for nash has been developed. nafld management is mainly dependent on diet control, physical activity, and some supportive treatments mainly to prevent the disease complications (mundi et al., 2020). mast cells (mcs) are responsible releasing mediators, including preformed bioactive metabolites (histamine and tryptase,), newly synthesized cytokines \[transforming growth factor beta (tgf-β), tumor necrosis factor alpha (tnf-α) (pham et al., 2022). mcs can lead to microvesicular steatosis, ductal reaction (dr), biliary senescence, inflammation, angiogenesis, and liver fibrosis during nafld/nash (huang et al., 2022). consequently, mc stabilizer such as ketotifen has emerged as promising approach to improve patients with nash through its antioxidant and anti-inflammatory effects (kim et al., 2014; abdelzaher et al., 2020).

Eligibility criteria:
-inclusion criteria: adult males or females aged ≥18 years. * all patients are diagnosed to have fatty liver grading 1, 2 or 3 on abdominal ultrasound with hepatic steatosis index \> 36 to be considered as a nafld patient. * confirmed diagnosis of nash * exclusion criteria: * current or history of significant alcohol consumption. * use of drugs historically associated with nonalcoholic fatty liver disease (nafld) (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins). * prior or planned bariatric surgery. * uncontrolled diabetes defined as hemoglobin a1c 9.5% or higher. * evidence of other forms of chronic liver disease as hepatitis b, hepatitis c, wilson's disease, alpha-1-antitrypsin (a1at) deficiency, hemochromatosis, drug-induced liver disease. * pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial and breast feeding. * use of other drugs known to have possible positive effects on steatosis. * other anti-histaminic, sedating agents (cns depressants) and anticholinergic medications.

Keywords: nonalcoholic fatty liver disease (nafld)
carbon monoxide measurement to screen for sickle cell disease

Conditions: Sickle Cell Anemia

Summary: modify the design of the cosense device (model c20112, currently cleared by the fda for etco (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature conditions encountered in countries with high prevalence of scd (sickle cell disease).

increase the temperature operating range of etco measurements to 5 to 45°c. the signal output-to-co (carbon monoxide) concentration correlation of the co sensor is dependent on temperature. the new algorithm will be a different approach because the current algorithm is at the limits of its capability. we will establish the new specifications by determining performance in a bench model under simulated temperature conditions. we will then determine the ability of the modified device to distinguish between scd and healthy controls. during this initial testing, we will examine the validity of etco measurements under regulated room temperature in the hospital setting. we will enroll 20 subjects, 10 each in the scd arm and control arm to determine the mean and variance of the etco values.

Eligibility criteria:
inclusion criteria: * parental / legal guardian consent * subject assent for participants ages 7 and above * male and female children ages 1-18 years old * for hb ss (homozygous sickle cell anemia) subjects, hemoglobin baseline hemoglobin ≤10 g/dl based upon average hemoglobin value in past year exclusion criteria: * subjects must not meet any of the following exclusion criteria to be considered eligible for study enrollment: * had a red blood cell transfusion within 8 weeks prior to enrollment * currently a primary smoker or was a primary smoker within 4 weeks prior to enrollment * exposed to second hand smoke within 24 hours prior to breath sample collections * have current upper respiratory infection or symptomatic asthma * for healthy subjects, known to have the sickle cell trait by electrophoresis or genetic testing

Keywords: sickle cell anemia
study of safety and efficiency of the use of neutral argon plasma in cyto-reduction of miliary implants in the peritoneal surface.

Conditions: Peritoneal Carcinomatosis

Summary: neutral argon plasma vaporization shows little damage to normal tissue and allows a complete removal of tumor tissue, that is, without leaving any cell debris viable tumor. our primary objective is to evaluate the effectiveness and safety of neutral argon plasma on peritoneal implants with different dosimetry in vivo and ex vivo.


Eligibility criteria:
inclusion criteria: * patients diagnosed with peritoneal carcinomatosis (an attempt will be made to cover all histological types of carcinomatosis in similar distribution as 2 patients with carcinomatosis of colonic origin, 2 patients with carcinomatosis of ovarian origin, 2 patients with peritoneal pseudomyxoma, 2 patients with peritoneal mesothelioma and 2 patients with carcinomatosis of gastric origin) with pci greater than 0 in regions 10-13, and that have been selected as candidates for cytoreductive surgery + hipec or for laparoscopy-laparotomy explorer (selection criteria established according to clinical practice usual), and that present peritoneal miliary dissemination consistent with the characteristics of this study for the tissue under examination (implants smaller than 0.25 cm, cc1). * signature of specific informed consent for participation in this study and to obtain biological samples. exclusion criteria: * patients not suitable for crs and hipec, according to the clinical criteria of the surgery unit oncology and multidisciplinary committee. * refusal of the patient to participate in the study.

Keywords: peritoneal carcinomatosis cancer neutral argon plasma
dendritic cell vaccine in hiv-1 infection

Conditions: HIV Infections

Summary: 1. to study the efficacy of a therapeutic hiv vaccine consisting of autologous myeloid dendritic cells pulsed ex vivo with high doses of inactivated autologous hiv-1, in hiv-1 infected patients in a very early stages of the disease (cd4 \> 450 x 10 6 /l). 2. to analyze the hiv-1 humoral and cellular immune responses induced by this immune-based therapy.

our group has reported recently the first human trial of 4 therapeutic immunizations at six-week intervals with autologous monocyte-derived dendritic cells (md-dc) loaded with heat-inactivated autologous hiv in 12 hiv infected patients who had been receiving highly active antiretroviral therapy (haart) since early chronic infection. autologous hiv was concentrated from plasma (1,500 ml) obtained by plasmapheresis after a 3-month haart interruption (stop1) performed 78 weeks before therapeutic immunizations, and haart was discontinued again (stop2) after therapeutic immunization. there was a decrease of set-point plasma viral load (pvl) \>= 0.5 log after 24 weeks off haart in 4 out of 12 patients. in addition, we observed a significant lengthening in mean doubling time of pvl rebound (p= 0.01), and significant decreases in the area under the curve of pvl rebound (p= 0.02) and in the mean peak pvl (p= 0.004) during the 12 weeks after stop 2 compared with stop1. this virological response was associated with a weak but significant increase in hiv-1 specific cd4 lymphoproliferative response, and with changes in hiv-1 specific cd8+ t-cell responses in peripheral blood and in lymphoid ctl cells after immunization. in lymphoid tissue, we also observed a trend towards a better control of hiv-1 replication coupled with an increase of cd4+ and ctl cells. no significant virological or immunological changes occurred in controls. we show that a therapeutic vaccine with autologous md-dc pulsed with heat inactivated autologous hiv-1 is feasible, safe and well tolerated and elicited weak and transient cellular immune responses against hiv, associated with a partial and transient control of hiv replication in some patients. we hypothesized that a dc vaccine pulsed with higher amount of autologous virus obtained by culture could be more effective than the vaccine we used.

Eligibility criteria:
inclusion criteria: * confirmed hiv infection * cd4 \> 450 x 10 6 /l * baseline vl \>10,000 c/ml before any haart * part i, patients off haart at least during 6 months * part ii, patients on haart with pvl \< 200 copies/ml at least during 6 months * written informed consent . exclusion criteria: * patients with failure to haart * patients with b or c symptoms (cdc classification 1993). * age \< 18 years old. * pregnant or breastfeeding women * patients with baseline creatinin \> 2.5 mg/dl * patients with baseline got/gpt \> 250 ui/l

Keywords: hiv infection dendritic cell vaccine autologous virus heat inactivated hiv therapeutic vaccine
etiology and prevalence of peripheral arterial disease

Conditions: Cardiovascular Diseases; Peripheral Vascular Diseases; Arterial Occlusive Diseases

Summary: to determine the prevalence of peripheral arterial disease in a defined population by non-invasive techniques; to evaluate the association of cardiovascular disease risk factors with peripheral vascular disease; to determine whether non-invasive tests of peripheral arterial disease can be utilized as markers for coronary heart disease; to determine the status of the microvasculature using conjunctival photographs and to compare the results with risk factors and the peripheral arterial disease testing results.

background: atherosclerosis is frequently generalized, affecting blood vessels in various parts of the body. previous studies had noted the strong association between peripheral arterial disease and coronary heart disease and the similarity of risk factors, particularly diabetes and cigarette smoking for both diseases. the natural history of peripheral arterial disease had not been delineated because of the lack, until recently, of accurate and reliable non-invasive testing. design narrative: all 624 subjects were initially studied under a lipid research clinic protocol that involved two evaluations, visit 1 and visit 2. at visit 2, half of the subjects were from a random sample of the lrc visit 1 cohort and others were selected from the visit 1 cohort for hyperlipidemia, defined as being at or above age- and sex-specific 90th percentiles for cholesterol or 95th percentiles for triglycerides or taking lipid-lowering medications. at visit 2, the subjects were characterized as to age; sex; drug, diet, alcohol and smoking history; personal and family history of cardiovascular disease; rose questionnaire; and electrocardiogram and examination by a cardiologist. the subjects were given a traditional manual examination for peripheral arterial disease and four non-invasive tests including segmental blood pressure, flow velocity by doppler ultrasound, postocclusive reactive hyperemia, and pulse reappearance half-time. the subjects were categorized into large vessel peripheral arterial disease, isolated small vessel peripheral arterial disease or normal based on the results of non-invasive testing and followed for an average of four years. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
cluster analysis to identify metabolic syndrome components and physical fitness in patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the components of mets (abdominal obesity, high blood pressure, high serum glucose, high triglyceride level and low hdl-c) differ according to demographic characteristics such as age, gender and comorbidities. low physical activity level, genetic makeup, nutritional disorders, decreased muscle strength and low cardiorespiratory fitness can be counted among the risk factors associated with mets. in our study, it was aimed to examine the relationship between the components of the mets and muscle strength, physical activity, functional capacity and quality of life. our secondary aim is to investigate the independent effects of different components of mets on each parameter.

the participants' sociodemographic characteristics such as age, height, weight, body mass index, waist circumference, marital status and education level, and anthropometric measurements, body fat percentage distributions, fasting blood glucose, hba1c and lipid profiles will be recorded from previous analysis reports. lower extremity quadriceps muscle strength hand-held dynamometer, grip strength hand dynamometer, physical activity level international physical activity questionnaire-short form-ipaq-sf, number of steps pedometer, functional capacity 6 minute walking test and quality of life will be evaluated with the european quality of life scale-5 dimension.

Eligibility criteria:
inclusion criteria: * to be diagnosed with mets by an internal medicine specialist according to ncep-atp iii criteria * finding abdominal obesity component according to turdep-ii criteria * being between the ages of 40-65 * to be able to read and write turkish * having signed the informed consent form exclusion criteria: * lack of cooperation * those with severe peripheral or central neurological disorders * patients with uncontrolled hypertension and uncontrolled arrhythmia * pregnant or breastfeeding patients * those with diabetic ulcer or neuropathy * chronic kidney failure (egfr\<30 ml/min) * chronic liver disease (alt/ast\<3x normal upper limit) * those with serious respiratory system disease * patients with cardiac pacemaker * history of previous stroke or myocardial infarction * presence of lower and upper extremity orthopedic problems that may prevent the application of clinical tests

Keywords: mets, physical fitness, physical activity, cluster analysis